(78 days)
HDR Sensor is is used for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
Not Found
The provided document is a 510(k) clearance letter for the HDR Sensor, an extraoral source x-ray system, and states its indications for use. It does not contain information about acceptance criteria for device performance, the study that proves the device meets those criteria, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/ML performance evaluation.
Therefore, I cannot fulfill your request using only the provided text. The document is a regulatory clearance and not a technical performance report or clinical study summary.
To answer your questions about acceptance criteria and study details, I would need a different type of document, such as:
- A clinical study report
- A validation report
- A performance specification document
- A detailed 510(k) submission summary (which often includes performance data)
Without this information, I cannot provide a table of acceptance criteria and reported performance, nor can I answer the specific questions about sample sizes, experts, ground truth, or AI study details.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.